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埃博拉临床试验:灾难研究伦理学的先例。

The Ebola clinical trials: a precedent for research ethics in disasters.

出版信息

J Med Ethics. 2018 Jan;44(1):3-8. doi: 10.1136/medethics-2016-103474. Epub 2016 Aug 29.

Abstract

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: (i) the specification of exceptional circumstances, (ii) the specification of unproven interventions, (iii) the goals of interventional research in terms of individual versus collective interests, (iv) the place of adaptive trial designs and (v) the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies.

摘要

西非埃博拉疫情促使人们开展了一项集体努力,即在发生重大公共卫生危机期间,加速进行临床试验,测试未经证实但具有潜在救生效果的干预措施。这项史无前例的工作得到了世界卫生组织(WHO)于 2014 年 8 月召集的一个特设伦理小组建议的支持。该小组通过考虑为什么以及在何种情况下,埃博拉疫情的特殊情况证明可以使用未经证实的干预措施,其建议对治疗开发和临床研究伦理的传统思维提出了挑战。与此同时,出现了一些未回答的伦理问题,特别是:(i) 特殊情况的具体规定;(ii) 未经证实的干预措施的具体规定;(iii) 干预研究在个人与集体利益方面的目标;(iv) 适应性试验设计的地位;以及 (v) 同情使用未经批准的干预措施的确切含义。同时对这些问题进行研究,并结合研究地点的实证数据,将有助于为灾难研究伦理建立实用的基础。此外,埃博拉临床试验标志着治疗研究当前范式的演变,超越了紧急疫情的情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6caf/5749307/32a21af944ab/medethics-2016-103474f01.jpg

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